An Evidence-Based Guide to Writing Grant Proposals for Clinical Research

Abstract

The competition for funds to conduct clinical research is intense, and only a minority of grant proposals receive funding. In particular, funding for patient-oriented research lags behind that allocated for basic science research. Grant writing is a skill of fundamental importance to the clinical researcher, and conducting high-quality clinical research requires funds received through successful grant proposals. This article provides recommendations for the grant-writing process for clinical researchers. On the basis of observations from a National Institutes of Health study section, we describe types and sources of grant funds, provide key recommendations regarding the process of grant writing, and highlight the sections of grants that are frequently scrutinized and critiqued. We also provide specific recommendations to help grant writers improve the quality of areas commonly cited as deficient. Application of this systematic approach will make the task more manageable for anyone who writes grants.

High-quality clinical research is essential to understanding disease and improving health care. Each research proposal should provide the potential to add to the existing body of knowledge, to advance understanding, and to alleviate human disease and suffering. However, converting the proposal into reality requires grant funding. In this era of budget cuts and deficits, obtaining peer-reviewed research funds has become ever more competitive. The overall rate of funding of new R01 applications by the National Institutes of Health (NIH) in 2003 was only 24.1% (of the 18 733 applications to all institutes, 4521 were awarded grants) (1). Obtaining funding for patient-oriented research may pose a particularly difficult challenge (2). In 2001, while the success rates for principal investigators with MD and PhD degrees were similar (35% and 31%, respectively), far fewer awards were made to MDs (2839) than to PhDs (6137) (3). The scientific director of the National Institute of Child Health and Human Development stated, “The number of physicians participating in patient-oriented research has fallen over the past decade for a number of reasons, while disease-oriented research, as informed by cell and molecular biology, has been on the ascendancy. A major issue … is the recent and dramatic decline in patient-oriented research, i.e., research that requires interaction between a physician-investigator and a patient” (4). Given this climate, understanding the essentials of grant writing is of fundamental importance to the academic clinical researcher—for career development and for advancement of clinical research projects and programs.

Writing a grant proposal forces the investigator to create, define, and refine the research project. In fact, the time spent to fully conceptualize and synthesize the proposal will enhance the investigator's ability to conduct a better study and will provide the framework for future reports of the work. The proposal should be innovative and exciting, and its conceptualization stimulates the investigator to develop a logical sequence for future activities. This article provides guidance on the grant-writing process for new clinical researchers, describes the most common critiques and comments on grant applications during peer review, and provides recommendations based on this evidence. While some principles may apply to basic science grants, this article is primarily intended for clinical researchers carrying out patient-oriented research. This article is not intended to provide instruction on conducting clinical research. More detailed information on conducting clinical research (5–8) is available elsewhere.